FDA Approves Bigfoot Unity Diabetes Management System

The U.S. Food and Drug Administration (FDA) has approved Bigfoot Biomedical’s Unity Diabetes Management System, a unique combination of software and a specialized insulin[1] pen cap with a screen that issues reminders and recommendations, as noted in a press release[2] from the company.

The newly approved management system is for people ages 12 and above with type 1[3] or type 2 diabetes[4] who receive multiple daily insulin injections. The Bigfoot Unity System[5] includes two smartpen caps, for both rapid-acting and long-acting insulin. These caps are electronic devices, each with a display screen, that communicate with an integrated FreeStyle Libre 2 sensor from Abbott for continuous glucose monitoring[6] (CGM), as well as with an included traditional blood glucose meter and a mobile app. Data from the CGM sensor is used to give insulin dosage recommendations, based on your doctor’s personalized recommendations.

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Using the Bigfoot Unity System

To use the smartpen for an injection of rapid-acting insulin (the “White Cap”), users scan the FreeStyle Libre 2 sensor to view their current glucose level along with a trend arrow. Glucose levels and insulin doses are both recorded automatically in the system’s software, so there’s a complete record of your glucose levels and insulin doses for you and your doctor to review. The system’s “Black Cap” for long-acting insulin displays the time since your last recorded dose of this insulin type, as well as the recommended dose for your next injection. This smartpen also connects with the mobile app and sends alerts for potential missed long-acting insulin doses.

While the CGM sensor’s readings are expected to inform most insulin doses in the Bigfoot Unity System, the system may recommend using a traditional “finger-stick” meter at certain times, and you can always use a traditional meter if you prefer to do so as part of the system. These readings are automatically integrated into the system, transmitted wirelessly, and used to create dosage recommendations. They’re also stored in the system along with your CGM data, for an integrated picture of your glucose levels over time.

Bigfoot Unity System[8]
The Bigfoot Unity System. (Image courtesy of Bigfoot Biomedical.)

The Bigfoot Unity System is compatible with all available major brands of both rapid-acting and long-acting insulin pens sold in the United States, including those sold by Eli Lilly, Novo Nordisk, and Sanofi. It will be available through select diabetes clinics starting in spring 2021.

“People with diabetes can be overwhelmed with the amount of data they get from multiple devices, so it’s important to develop connected technologies that simplify the experience,” said Jared Watkin, senior vice president for Diabetes Care at Abbott, in the Bigfoot press release. “Through Abbott’s collaboration with Bigfoot Biomedical, we’re integrating our revolutionary, easy-to-use FreeStyle Libre 2 technology with the Bigfoot Unity System to provide automated information for personalized diabetes management.”

“Diabetes management is incredibly hard because insulin has no fixed dose or timing, leaving individuals to constantly determine their doses and configure devices as they make multiple critical decisions every day about how much insulin to take,” added Jeffrey Brewer, CEO of Bigfoot Biomedical, in the press release. “At Bigfoot, we want to ease the burden of diabetes for people taking insulin by minimizing the anxious guesswork involved with insulin dosing in a convenient, simple way.”

Want to learn more about insulin? Read “What Does Insulin Do?”[9] “Insulin: What You Need to Know”[10] and “Insulin Basics.”[11]

Endnotes:
  1. insulin: https://www.diabetesselfmanagement.com/blog/what-does-insulin-do/
  2. press release: https://www.bigfootbiomedical.com/fda-clearance-bigfoot-unity
  3. type 1: https://www.diabetesselfmanagement.com/diabetes-resources/definitions/type-1-diabetes/
  4. type 2 diabetes: https://www.diabetesselfmanagement.com/diabetes-resources/definitions/type-2-diabetes/
  5. Bigfoot Unity System: https://www.bigfootbiomedical.com/bigfoot-unity
  6. continuous glucose monitoring: https://www.diabetesselfmanagement.com/managing-diabetes/blood-glucose-management/cgm-diabetes-management/
  7. sign up for our free newsletters: https://www.diabetesselfmanagement.com/newsletter/
  8. [Image]: https://cdn.diabetesselfmanagement.com/2021/05/bigfoot-unity.png
  9. “What Does Insulin Do?”: https://www.diabetesselfmanagement.com/blog/what-does-insulin-do/
  10. “Insulin: What You Need to Know”: https://www.diabetesselfmanagement.com/blog/insulin-what-you-need-to-know/
  11. “Insulin Basics.”: https://www.diabetesselfmanagement.com/managing-diabetes/treatment-approaches/insulin-basics/

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